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CTRI Number  CTRI/2018/03/012726 [Registered on: 21/03/2018] Trial Registered Retrospectively
Last Modified On: 20/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assess the use of Gum-paint and Tablets applied over gums along with Cleaning in Diabetic patients with Gum Disease. 
Scientific Title of Study   Evaluation of Efficacy of G32TM Gum paint and G32TM Tablets as an adjunct to Scaling in Diabetic patients with Chronic Periodontitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shraddha Kode 
Designation  First year post-graduate student 
Affiliation  Nair Hospital Dental College 
Address  S/3 A Chitralekha Vikram Nagar Kalwa(w). Dist - Thane 400605
S/3 A Chitralekha Vikram Nagar Kalwa(w). Dist - Thane 400605
Thane
MAHARASHTRA
400605
India 
Phone  9773752150  
Fax    
Email  kshraa24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praneeta Kamble 
Designation  Associate Professor 
Affiliation  Nair Hospital Dental College 
Address  202, Second floor, Department of Periodontology, Nair Hospital Dental College, Mumbai Central, Mumbai-08

Mumbai
MAHARASHTRA
400008
India 
Phone  9820263468  
Fax    
Email  drpraneetakamble@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shraddha Kode 
Designation  First year post-graduate student 
Affiliation  Nair Hospital Dental College 
Address  S/3 A Chitralekha Vikram Nagar Kalwa(w). Dist - Thane 400605
S/3 A Chitralekha Vikram Nagar Kalwa(w). Dist - Thane 400605
Thane
MAHARASHTRA
400605
India 
Phone  9773752150  
Fax    
Email  kshraa24@gmail.com  
 
Source of Monetary or Material Support  
Alarsin Pharmaceuticals, Andheri east, Mumbai, Maharashtra 
 
Primary Sponsor  
Name  Alarsin Pharmaceuticals 
Address  Alarsin House, Plot No-A/32, Street No 3, M I D C, Opposite Esis Hospital, Andheri (E), Mumbai, Maharashtra 400093 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shraddha Kode  Nair Hospital Dental College  Department of Periodontics Second floor, Nair Hospital Dental College, Opposite Maratha Mandir, Mumbai - 08
Mumbai
MAHARASHTRA 
9773752150

kshraa24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethical Committee, Nair Hospital Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diabetic patients with Chronic Periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sacling in Diabetic patients with Chronic Periodontitis  Gold standard treatment done at baseline 
Intervention  Use of G32 Gum paint and tablets in Diabetic patients with Chronic Periodontitis  It is an adjunctive aid used along with Scaling twice daily for first 15 days followed by once daily for the next 15 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age group between 25-70 years.
2. Patients with controlled diabetes (on oral hypoglycemic drugs) with glycosylated haemoglobin (HbA1c) levels < 7
3. Patients with chronic periodontitis having periodontal pocket depth less than 4mm
4. Patients with minimum of 20 teeth.
5. Patients who have not received any type of periodontal therapy for the past 6 months
 
 
ExclusionCriteria 
Details  1. Patients on insulin therapy
2. Patients suffering from any other systemic disease or with compromised immune system.
3. Patients with a known history of drug allergy
4. Patients taking any drug known to cause gingival enlargement
5. Patients taking any immuno-suppressive drugs like corticosteroids.
6. Pregnant and/or lactating mothers.
7. Patients with any bleeding disorders.
8. Patient on anticoagulant therapy.
9. Patients with smoking and tobacco chewing habits.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will help to evaluate an adjunct to scaling in Diabetic patients with Chronic Periodontitis for control or regression of gingival inflammation.   Baseline and 1 month follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of gingival, plaque scores, probing pocket depth and clinical attachment loss  Baseline and 1 month follow up  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   03/04/2017 
Date of Study Completion (India) 15/11/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Periodontitis has been identified as the sixth complication of diabetes1. Diabetes has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and public health costs. The presence of diabetes might impair the prognosis of periodontal treatments due to its negative influence on wound healing.

 

Periodontal diseases are a group of inflammatory conditions resulting from

interaction between a pathogenic bacterial biofilm and susceptible host’s

inflammatory response eventually leading to the destruction of periodontal structures

and subsequent tooth loss. Inflammation is an immunologic response involving blood vessels and blood cells to local injury, infection, hypersensitivity, physical reaction, chemical reaction, necrosis of tissues and emotional stress.

 

Scaling is considered as the gold standard treatment for these conditions2. As an adjunct to scaling many chemical and herbal formulations have been tried and found to be efficacious in the past. Chemical preparations are known to cause conditions such as drug resistance with reports of drug allergy along with staining of teeth, and thus a shift toward the herbal remedies has been seen in the near past and gaining popularity in present.

From the dawn of history man has sought to cure diseases with use of medicinal plants. Ayurveda is believed to have developed somewhere during the period 2800-500 B.C. In India, systematic work on scientific lines of herbal medicines was organised by Sir R.M. Chopra. In the field of dentistry few herbal medicines have been showing encouraging results. Use of tannic acid have been advocated for the treatment of gingivitis. Use of neem as datun has been advised for freshening the mouth.

G32TM is an ayurvedic preparation marketed by ALARSIN. G32TM has been described as having antiseptic, anti-inflammatory, astringent, styptic, anodyne and other properties. G32TM, used in this study, is one such ayurvedic preparation. It is available for local application, in an easily crushable tablet form and as gum paint. The main ingredients in this ayurvedic preparation include Bakul, Chok, Katha, Laving, Fatakdi, etc.

Constituents of G32TM

Bakul (Mimosops elangi) - 80 mg.

Chok (Calcium Carbonate) - 75 mg.

Katho (Acacia catechu) - 40 mg.

Laving (Myrtus caryophyllus) - 20 mg.

Chikani Sopari (Areca catechu) - 20 mg.

Fatakadi (Alumen) - 20 mg.

Mayafal (Quercus infectoria) - 20 mg.

Elaichi (Elettaria cardamomum) - 10 mg.

Sonageru (Silicate of Alumina and Iron Oxide) - 10 mg.

Jiru (Carum carvi) - 10 mg.

Majith (Rubia cordifolia) - 10 mg.

Pashanbed (Saxifrua ligulata) - 10 mg.

Vavding (Embelia ribes) - 10 mg.

Pipala ni Lakh (Ficus religiosa) - 10 mg.

Samudrafin (Os sapiae) - 10 mg.

Vajradanti (Barleria prioitis) - 10 mg.

Taj (Cinnamimum cassia) - 5 mg.

Mari (Piper nigrum) - 5 mg.

Sajikhar (Sodium carbonate impure) - 5 mg.

Kulinjan (Alpinia chinensis) - 5 mg.

Pipar (Piper longum) - 5 mg.

Kapur (Camphora officinarum) - 5 mg.

Kuth (Uncaria gambier) - 5 mg.

G32TM can be used for gum massage, dentrifice, rinse and gargle. G32TM is found to be an effective and a safe drug in gingivitis, acute or chronic, localised or generalised, and even when associated with painful teeth and bleeding gums.6

AIM OF STUDY:

To introduce a natural adjunct that effectively reduces inflammation in Diabetic patients with Chronic Periodontitis

OBJECTIVES OF THE STUDY:

1.    To evaluate the efficacy of G32TM gum paint and tablets as an adjunct to Scaling in Diabetic patients with Chronic.

2.    To compare the efficacy of G32TM gum paint with tablets in Diabetic patients with Chronic Periodontitis post scaling Periodontitis

 
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